Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel

Phase 2

Completed

• Conditions: Primary Breast Cancer

• Registration Number: NCT00527449
• Lead Sponsor: Klinikum Weissenfels

Brief Summary

The purpose of this study is to optimize results in neoadjuvant chemotherapy of local advanced primary breast cancer. Therefore patients become first 3 cycles of Epirubicin/Docetaxel followed by 3x Carboplatin/Docetaxel.

Detailed Description

Most of the women who are diagnosed with breast cancer are in the situation that an operation is possible. Using a neoadjuvant therapy the rate of breast-conserving surgery can be extended and tumor cell proliferation may be inhibited. Further the neoadjuvant chemotherapy is an in-vivo-activity-test for the used drugs. Epirubicin, Docetaxel and Carboplatin have shown antineoplastic activity against solid cancer alone and in combination.

Using two different combinations of these three drugs, first 3 cycles Epirubicin/Docetaxel and then changing to Carboplatin/Docetaxel for 3 further cycles it is assumed that the results of the therapy will improve. Main criterion is the determination of pCR, second criteria are the rate of breast-conserving surgery, tumor response and therapy-dependent toxicities.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• histologically assured breast cancer
• age >= 18 years
• bone marrow function: neutrophils >= 1.5x109/l, platelets >= 100x109/l, hemoglobin >=6.2 mmol/l
• sufficient renal and liver function
• ECOG 0-2
• written informed consent

Exclusion Criteria

• pregnant or nursing women
• distant metastases
• T2-Tumour < 3cm and G1
• existing motoric or sensoric neurotoxicity > Grade 2
• known hypersensitivity against Epirubicin or other anthracycline or against Carboplatin or other platin derivatives or against Docetaxel or against substances in the preparing solutions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determining pathologic complete remission under study treatment	28 days after last administration of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Rate of breast conserving operations	28 days after administration of last chemotherapy
Response to treatment	28 days after last administration of chemotherapy
Determining the therapy associated toxicity	28 days after last administration of chemotherapy

Trial Locations

Locations (3)

Krankenhaus St. Elisabeth u. St. Barbara; 🇩🇪 Halle, Sachsen-Anhalt, Germany

Asklepios Krankenhaus Weissenfels; 🇩🇪 Weissenfels, Sachsen-Anhalt, Germany

Klinikum Marienstift; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany